FDA product code JQO: Balance, Analytical
JQO is the FDA product code for balance, analytical. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. Devices under JQO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Balance, Analytical |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for JQO devices
openFDA lists no recalls for product code JQO.
Frequently asked questions
What is FDA product code JQO?
JQO is the FDA product code for balance, analytical. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JQO?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code JQO
- Run a recall and safety report across every JQO manufacturer
- Watch product code JQO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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